Preliminary Evaluation of Uptake of [68Ga]P16-093 in Metastatic Prostate and Renal Cancer

Preliminary Investigation of Uptake in PSMA Expressing Cancer, Biodistribution and Excretion of the Novel Radio Tracer [68Ga]P16-093 by PET/CT

An phase I study to evaluate the uptake of [68Ga]P16-093 in known or suspected metastatic prostate or renal cancer to establish the feasibility of using [68Ga]P16-093 to image PSMA expressing cancer. Measurement of the whole body biodistribution of [68Ga]P16-093 in prostate cancer patients post primary curative-intent treatment with stable PSA to generate human radiation dosimetry data.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer; Renal Cancer
• Intervention / Treatment: Drug: [68Ga]P16-093

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

DYNAMIC GROUP:

Inclusion Criteria:

1. Participants will be male ≥ 18 years of age

2. History of histologically confirmed cancer that meets criteria for either a) or b)

   1. Prostate cancer with known or suspected recurrent or metastatic disease based on clinical imaging (e.g. CT, bone scan, MRI, ultrasound, FDG PET/CT, FACBC PET/CT) within 12 months of screening. If subject is post curative-intent local treatment (e.g. radical prostatectomy, local radiotherapy, brachytherapy) they must have had no intervening change in cancer treatment.

      OR

   2. Renal Cell cancer with known or suspected metastatic disease based on clinical imaging (e.g. CT, bone scan, MRI, ultrasound, FDG PET/CT)
3. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

1. Estimated creatinine clearance (eGFR) < 30 mL/min (calculated from serum creatinine result within 30 days of screening)
2. Chemotherapy or radiation therapy within 2 weeks of screening
3. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
4. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful completion of the study

BIODISTRIBUTION GROUP:

Inclusion Criteria:

1. Participants will be male ≥ 18 years of age

2. History of prostate cancer that is post curative-intent local treatment (e.g. radical prostatectomy, local radiotherapy, brachytherapy) with clinical PSA levels that meet one of the following criteria

   1. Post-Prostatectomy (with or without adjuvant RT): PSA level that is < 0.2 ng/mL measured over at least 2 consecutive tests OR
   2. Post-Radiotherapy: PSA level that has not risen from nadir measured over at least 2 consecutive tests
3. If clinical imaging (e.g. bone scan, CT, MRI, ultrasound, PET/CT) has been done within 3 months of screening as part of standard clinical surveillance it must be negative or equivocal for sites of recurrent or metastatic disease (clinical imaging is not required for enrollment)
4. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

1. Estimated creatinine clearance (eGFR) < 30 mL/min (calculated from serum creatinine result within 30 days of screening)
2. Androgen deprivation therapy (ADT) within 3 months prior to screening
3. Chemotherapy or radiation therapy within 2 weeks of screening
4. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
5. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful completion of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic group; Dynamic imaging of suspected metastatic lesions with the investigation drug [68Ga]P16-093 in patients with a history of histologically confirmed cancer.	Drug: [68Ga]P16-093; Imaging by Positron Emission Tomography after iv injection of [68Ga]P16-093
Experimental: Biodistribution group; Whole body imaging to determine human dosimetry of the investigational drug [68Ga]P16-093	Drug: [68Ga]P16-093; Imaging by Positron Emission Tomography after iv injection of [68Ga]P16-093

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of [68Ga]P16-093 in metastatic prostate and renal cancer	Standard uptake value (SUV) of [68Ga]P16-093 in apparent lesions detected by PET/CT.	0.5 - 3 hours after injection
Radiation dosimetry of [68Ga]P16-093 in patients with a history of prostate cancer	Radiation dosimetry (organ absorbed dose and effective dose) will be determined using region of interest data drawn on sequential PET/CT images and data from blood and / or urine obtained during scanning.	up to 3 hours after injection

Collaborators and Investigators

• Sponsor: Five Eleven Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2017
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: 511-0003-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No